RecruitingNAINTERVENTIONAL

The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis

This study is checking a new smartphone app called ME&MG designed for people living with Myasthenia Gravis (MG). MG is a condition that causes muscle weakness. The app helps you check your symptoms at home, including things like drooping eyelids (ptosis), breathing, speech difficulties, and weakness in your arms and legs. It also includes questionnaires about daily activities, pain, tiredness, sleep, and mood. The main goal of the study is to see if using this app at home to monitor your symptoms is as accurate and reliable as the usual tests doctors do in a clinic. We also want to understand if the app is safe, easy to use, and if patients find it helpful. This could potentially make monitoring your MG easier and more convenient in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Ad scientiam

Enrolment target

144

Start

24 Jan 2024

Estimated completion

24 Sep 2026

Myasthenia Gravis

What is this study about?

Living with Myasthenia Gravis (MG) can mean frequent visits to the clinic for assessments of your muscle strength and overall well-being. These traditional clinic-based tests, while important, can sometimes be time-consuming and require special equipment. This study aims to explore a more convenient way for people with MG to keep track of their symptoms from the comfort of their own homes.

Researchers have developed a new smartphone app called ME&MG. This app contains various digital activities and questionnaires designed to measure common MG symptoms. For example, it can assess things like how well you can open your eyes, your breathing, how clearly you speak, and the strength in your arms and legs. It also asks about aspects of your daily life, such as pain, fatigue, sleep, and how you're feeling emotionally. The information you provide through the app can then be shared with your doctor through a special secure website.

The main purpose of this study is to compare how well the ME&MG app works against the standard tests you would normally do in a clinic. We want to find out if the app is accurate, reliable, and gives similar results to in-person assessments. We'll also be looking at how safe the app is to use, how easy patients find it, and if it improves their experience of managing their MG. If successful, this app could offer a new, simpler way to monitor your MG between clinic visits.

Key takeaways

This study evaluates a new smartphone app for Myasthenia Gravis (MG) monitoring.
The app aims to make tracking MG symptoms, like weakness and breathing, easier at home.
Researchers will compare app results to traditional clinic assessments to check accuracy.
Participation involves using your own smartphone for self-assessments.
The study also looks at how safe, user-friendly, and satisfying the app is.
It could offer a more convenient way to manage MG between doctor visits.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with a type of Myasthenia Gravis called 'generalised MG', which affects muscles in many parts of your body. Your doctor will need to confirm that your MG fits certain criteria and that you're not likely to need help breathing during the study. You also need to have specific antibodies in your blood that are typical for MG.

Crucially, you must own a smartphone (iPhone with iOS 13 or newer, or Android with version 8 or newer) and be comfortable using it. You'll also need to be able to read and understand information in French, English, or Spanish, and understand pictures within the app.

There are also some reasons why you wouldn't be able to join. For example, if you've recently had certain treatments like a thymectomy (surgery to remove the thymus gland), plasma exchange, or intravenous immunoglobulin therapy within the last four weeks. Also, if you've recently started a new type of MG medication called an FcRn inhibitor within the same timeframe, or if you are pregnant or breastfeeding. The research team will also consider if any other health conditions or medications might affect your participation or the study results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of generalised Myasthenia Gravis?
Do you own a smartphone (iPhone iOS 13+ or Android 8+) and know how to use it?
Can you read and understand English, French, or Spanish?
Have you avoided certain MG treatments (like plasma exchange or specific medications) in the last 4 weeks?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

This study involves using the ME&MG mobile application on your own smartphone. You will be asked to complete various digital tests and questionnaires within the app at home. These assessments cover things like your eye movements, breathing, speech, and strength in your arms and legs, as well as questions about your daily life, pain, and sleep. The study will compare these home-based assessments with the standard tests you would usually have during clinic visits. The exact number of assessments and duration of your participation will be explained by the study team, but it focuses on unsupervised self-assessment at home. There will be no specific medication given as part of this study.

Potential risks and benefits

Potential benefits of taking part include the opportunity to use a new digital tool that could make monitoring your MG symptoms more convenient. If the app is successful, it might help improve how MG is followed between clinic visits. There are very few direct risks associated with using a smartphone app, but like any research, there's always a small chance of unexpected discomfort or inconvenience. Any information you provide would be kept confidential. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (19)

University of Colorado Denver
Verified postcode
Aurora, United States· Recruiting
University of Florida Health
Verified postcode
Jacksonville, United States· Recruiting
HealthParterns Institute
Verified postcode
Bloomington, United States· Completed
Indiana University Health
Verified postcode
Indianapolis, United States· Recruiting
University of Kentucky
Verified postcode
Lexington, United States· Recruiting
Neurological Associates of Long Island, P.C.
Verified postcode
Lake Success, United States· Recruiting
Duke University
Verified postcode
Durham, United States· Recruiting
OHSU
Verified postcode
Portland, United States· Recruiting
Thomas Jefferson University
Verified postcode
Philadelphia, United States· Recruiting
The University of Tennessee Medical Center
Verified postcode
Knoxville, United States· Not yet recruiting
Vanderbilt Health
Verified postcode
Nashville, United States· Recruiting
Hôpital Raymond Poincaré
Verified postcode
Garches, France· Recruiting

Common questions

What is Myasthenia Gravis?

Myasthenia Gravis (MG) is a condition that causes muscle weakness. It happens when your body's immune system accidentally attacks parts of your muscles.

What is the ME&MG app?

It's a smartphone app designed to help people with MG check their symptoms at home, such as muscle weakness, breathing, and speech, and answer questions about their daily life.

Why is this study important?

This study aims to find out if using a smartphone app to monitor MG at home is as accurate and reliable as hospital visits, potentially making symptom tracking easier for patients.

Do I need to come to the clinic often for this study?

The study focuses on using the app for self-assessment at home, but it will compare those results to standard clinic tests. The team will explain the schedule for any clinic visits.

Will I get any medication in this study?

No, this study is about testing a smartphone app, not new medications. You'll continue with your usual MG treatment.

How to find out more

Pr Laforet

pascal.laforet@aphp.fr +33147107752 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.